Fusion Pro 24 Laser Safety Interlock Fails, Allowing Dangerous Radiation Exposure
Epilog Laser Corp. is recalling Fusion Pro 24 Model 17000 laser systems because an incorrectly placed interlock device allows the front-loading door to open during operation, potentially exposing users to Class 4 laser radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a laser device with a safety interlock defect allowing Class 4 laser radiation exposure. No injuries or illnesses have been reported, but the hazard represents a significant risk of harm.
Plain-English summary
Epilog Laser Corp. is recalling certain units of its Fusion Pro 24, Model 17000 laser system due to an incorrectly placed interlock safety device. The defect allows the front-loading door to open during operation, exposing users to Class 4 laser radiation.
This exposure violates the device's Class II safety designation and creates a risk of serious injury. The affected units were distributed nationwide in the United States.
The recalled product
- Product
- Fusion Pro 24, Model 17000
- Manufacturer
- Epilog Laser Corp.
- Category
- Medical Device
- Affected units
- 751
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model 17000 Product Report Accession Number: 2021046-000
Distribution
Distributed nationwide across the United States.
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